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NCT01948908 · ClinicalTrials.gov registry record · Phase 2
Volumes of Administration for Intranasal Midazolam
A Phase 2 study, sponsored by Columbia University.
- Completed
- Registry status
- Phase 2
- Development phase
- 99
- Enrollment target
NCT01948908: Completed Phase 2 study, sponsored by Columbia University.
NCT01948908 is a Phase 2 study that has completed, run by Columbia University. The registered enrollment target is 99 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01948908, a Phase 2 study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 99 participants
- Enrollment target
Study Summary
The purpose of this study is to determine exactly how much drug volume should be administered into each nare, so that the drug absorption can be maximized and the amount that runs out of the nose, or is swallowed, is minimized, thereby optimizing the effectiveness of any drug given intranasally. The investigators will determine this ideal "volume of administration" by studying intranasal midazolam in children who require sedation to facilitate laceration repairs. The investigators will evaluate both clinical outcomes as well as pharmacokinetic outcomes associated with each volume of administration. We will block randomize children to receive intranasal midazolam in maximum aliquots of one of the three following VOA: 200 microliters (mcL), 500 mcL, or 1000 mcL.
Primary Outcome
This outcome is designed to examine time to onset of minimal sedation, defined as a University of Michigan Sedation Score (UMSS) of 1.
Interventions
- DRUG Intranasal midazolam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 99 participants |
| Start Date | 2013-06 |
| Est. Completion | 2015-09 |
| Phase | Phase 2 |
What the finished NCT01948908 record still lists
NCT01948908 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 99 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% lower).
The record links to 0 conditions, and to 1 intervention - of which Intranasal midazolam is the first listed.
NCT01948908 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01948908 about?
NCT01948908 is a clinical study titled "Volumes of Administration for Intranasal Midazolam". The purpose of this study is to determine exactly how much drug volume should be administered into each nare, so that the drug absorption can be maximized and the amount that runs out of the nose, or is swallowed, is minimized, thereby optimizing the effectiveness of any drug given intranasally. The...
What is the current status of trial NCT01948908?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 99 participants. The study started on 2013-06. Estimated completion is 2015-09.
What interventions are being tested in trial NCT01948908?
The interventions under investigation include: Intranasal midazolam (DRUG).
Who is sponsoring clinical trial NCT01948908?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01948908's enrollment target sits among peer trials
99 738th of 2000 higher than 1,258 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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